Roles and Responsibilities:
Conducts reviews of laboratory paperwork and report to ensure all testing is appropriately documented and reported.
Issues Laboratory Notebooks and maintains lot numbering database
Conducts Facility inspection and method inspection in the labs to ensure the labs operate following ISO standards and USP SOPs and perform test following methods
Attends internal process audit and external audit of ISO 9001
Assists in investigations of unexpected results and deviation, and follow up the actions
Supports Quality Management Systems such as the Deviation, Lab investigation, CAPA and Document Control.
Identifies trends and problems based on data analysis, and reports accordingly.
Works as a team member for process improvement or initiatives and assisting in all other day-to-day QA activities.
A Master’s degree majored on biologics and biotechnology, or related science and technology, with at least 3 years of QA experience in pharmaceutical/biotech type industry, it is preferable to additionally have experience in laboratory of pharmaceutical/biotech type industry for at least 2 years.
KSAs and Training and Experience:
Working knowledge of MS Word, Excel and PowerPoint are required.
Good problem solving skills are required
Good technical writing and auditing skills are required.
Candidate must understand GMP, GLP, or ISO regulations and the integration of the regulations into working systems in the laboratory and site.
Excellent communication Skill
Teamwork and result driving